# K961294: Scimed Dispatch Gold Coronary Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Scimed Life Systems, Inc.
- Decided: Jul 3, 1996 after 90 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K950615 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953133: Scimed Dispatch Coronary Infusion Catheter, Scimed Life Systems, Inc. (1996) Summary page 1.
- K950615: Kaplan-Simpson Infusasleeve Catheter, Localmed, Inc. (1995) Summary page 1.

## Cited in the summary but kept off the family tree
- K940029: SCIMED UltraFuse Coronary Infusion/Guide Wire Exchange Catheter. The summary prints BK940029, a CBER number, which our reading took as K940029, which is not in FDA’s 510(k) list. Kept off the family tree. Summary page 1.

## Indications for use
The Dispatch Gold Coronary Infusion Catheter is intended for controlled and selective infusion of solution(s), including thrombolytic agents, into the vessel.

Source page: https://510kreport.com/device/K961294
Methodology: https://510kreport.com/methodology